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PHUSE Monthly News & Updates July 2019 | |
Dear PHUSE Member,
We have another very exciting month ahead here at PHUSE. Records have been broken and registrations are open!
There are three new Streams at the EU Connect in Amsterdam this year, and registration and Call for Papers are now open for the US Connect 2020. We also have a summary of this year's record-breaking CSS and the transition of two guidance papers from TransCelerate BioPharma Inc.
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EU Connect 2019: Register Now | |
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With just 20 weeks to go, plans for our event are well underway. Register your place by 26th July to benefit from the discounted Early Bird rate.
| With a record number of abstract submissions, this event is going to be extremely popular and highly likely to reach capacity! 18 Streams are on the agenda this year – so there is something of interest for everyone, including 3 NEW Streams:
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Professional Development
"Tools and skills to advance your career"
Personnel Management "Techniques, tools and experiences for effective management of people Leadership and Innovation "Innovative thinking, pushing boundaries and providing a platform for sharing these experiences"
For more information on all of the Streams and what is being presented, | |
Connect Hotel
This year, we have secured rooms at the Ramada Apollo Amsterdam Centre. Book via the PHUSE website by the end of August for the discounted rate.
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Exhibition space is now full; however, limited sponsorship opportunities are available. To see our current sponsors and exhibitors, and available opportunities, click here.
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US Connect 2020: Registration Open | |
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Connect Hotel
We have secured a block of rooms at the Renaissance Orlando at SeaWorld. Book via the PHUSE website for the discounted rate.
| | 8th–11th March, Orlando, FL, USA
View our flyer for all information on the event, including the agenda and Streams.
| Call for Papers is open. Submit your abstract here.
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For the annual Single Day Event schedule, click here. | |
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US CSS 2019 Silver Spring | |
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With a record number of Poster submissions for our 8th Computational Science Symposium, it was clear to see that this would be yet another successful PHUSE event!
Almost 260 attendees congregated at the Civic Center in Silver Spring to hear 7 keynote speakers from the FDA, to participate in 4 workshops, and to learn and share their experiences in over 30 breakout sessions.
Congratulations to our CSS Winners – view the blog post by clicking the link. | |
One of the CSS Award Winners
Anders Vidstrup: Cloud Adoption Project Lead, Emerging Trends & Technologies
Anders Vidstrup is Project Lead for the Cloud Adoption project. Since taking on this responsibility, he has worked tirelessly with the team to co-ordinate and develop a set of comprehensive guides for implementing cloud services for regulated use. | | | |
Presentations and posters, together with a list of all our CSS award winners, can be found here on the PHUSE website.
We would like to take this opportunity to thank each and every one of you who has made this possible and for your valued contributions. We truly did Connect, Share, Advance!
Make sure you save the date for next year's CSS: 14th–16th June 2020.
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Last month, PHUSE successfully transitioned two guidance papers from TransCelerate BioPharma Inc. under its umbrella. These guidance documents address clinical data transparency and the de-identification and anonymisation concerning individual patient data.
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The first paper is “Protection of Personal Data in Clinical Documents–A Model Approach,”. The second is “De-identification and Anonymisation of Individual Patient Data in ClinicalStudies–A Model Approach (V2.0),”. View the papers on our White Papers page on the PHUSE website.
To view the press release and find out more information, click here. | |
Deliverables
The PHUSE Optimizing the Use of Data Standards Working Group has published a White Paper on Define-XML Version 2.0 Completion Guidelines. Click here to view the paper.
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The Optimizing the Use of Data Standards Working Group has a new project calling for volunteers. The SDSP-XML project is looking to provide a prototype SDSP-XML package following on from the DRG-XML project which is developing a machine readable version of the Study Data Standardisation Plan (SDSP) as XML.
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The Open Source Technologies in Clinical Research project is aiming to provide guidance to the use of open source technologies in regulatory environments within the pharmaceutical industry, including, but not limited to R and Python. The goal is to broaden the acceptances and general level of comfort with these technologies in the industry to assist in increasing their level of adoption.
The new Real World Evidence project within Emerging Trends and Technologies aims to develop a white paper/presentation focussed on establishing the range of areas that need to be considered/impact on the use of RWE in support of regulated clinical trial submissions. This would be focussed on identifying issues such as data sources, RWE technologies, data privacy and related issues, standards etc. impacting on RWE use.
Interested in volunteering for the Working Groups? Contact workinggroups@phuse.eu for more information on how you can get involved.
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Webinar Wednesday 24th July 2019
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The agenda for this month's Webinar Wednesday will focus on our EU Connect 2019 in Amsterdam and the Early Bird registration deadline, as well as an introduction to the US Connect 2020 in Florida.
Register for the Webinar here. | |
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Board Vacancies and Volunteer Opportunities | |
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If you do have the time and are interested in becoming more involved with PHUSE, whether that be in a Board position, or supporting our various activities across the Working Groups, Events, Membership or Marketing & Communications teams, please let us know at office@phuse.eu.
Board Vacancies EMEA Director – an EU based volunteer is required Operations Director Membership Director Special Projects Director Collaborations Director – a US based volunteer is required
Board positions are held on a three-year tenure. Further details of the vacant Board of Director roles can be found on the website here. | |
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Click on the above image for information on PHUSE advertising opportunities. If you would like your advert to feature in the PHUSE Monthly News, please contact our Marketing & Communications team at communications@phuse.eu.
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Telephone: +44 1843 609600 www.phuse.eu
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